Uterine Cervical NeoplasmsNCT01944722
Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
A study testing BD Onclarity™ HPV assay on BD Viper™ LT and Colposcopy in people with Uterine Cervical Neoplasms, run by Becton, Dickinson and Company at 41 sites in United States.
Trial summary
The purpose of the study is to compare the results of the Becton Dickinson (BD) Onclarity™ Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology (LBC) media diluted in BD HPV LBC diluent to adjudicated histology results from biopsy and a molecular composite comparator. Read more about this study
- Who is it for?
- Ages 21 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Uterine Cervical Neoplasms
- What is being tested?
- BD Onclarity™ HPV assay on BD Viper™ LT and Colposcopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33,858 participants
- Where
- 41 sitesUnited States
- Study dates
- Aug 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Females who are >21 years of age
- Females who provide informed consent
Who cannot join
- Known pregnant
- Cervical cytology specimen collected within the last 4 months
- Prior complete or partial hysterectomy involving removal of cervix
- Application of chemical compounds to the cervical area 24 hour prior to study entry- acetic acid, iodine, spermicide, douche, or anti-fungal medications
- Conization, Loop Electrosurgical Excision Procedure (LEEP), cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
- Enrolled in a cervical disease diagnostic trial since 2007.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
TriCore Reference Laboratory
Albuquerque, New Mexico, 87102
University of Alabama Birmingham
Birmingham, Alabama, 35294
Fellows Research Associates - Bluffton
Bluffton, South Carolina, 29910
LabCorp
Burlington, North Carolina, 27215
Women's Health Practice
Champaign, Illinois, 61820
Chattanooga Medical Research
Chattanooga, Tennessee, 37404
Blueskies Center for Women
Colorado Springs, Colorado, 80910
Medical Network for Education and Research
Decatur, Georgia, 30033
Physicians Research Options
Draper, Utah, 84020
Research Pathology Associates
Earlysville, Virginia, 22936
HWC Women's Research Center
Englewood, Ohio, 45322
Indiana University
Indianapolis, Indiana, 46202
Research Pathology Associates, LLC
Irvington, New York, 10533
Health Awareness Inc
Jupiter, Florida, 33458
Altus
Lake Worth, Florida, 33461
Center for Women's Health of Lansdale
Lansdale, Pennsylvania, 19446
Mobile OB/GYN
Mobile, Alabama, 36608
Vitura / Phoenix
Moorestown, New Jersey, 08057
Meridian Health
Neptune City, New Jersey, 07753
Eastern Carolina Women's Center
New Bern, North Carolina, 28562
Louisiana State University
New Orleans, Louisiana, 70112
James T Martin Jr, MD
North Charleston, South Carolina, 29406
Segal Institute for Clinical Research
North Miami, Florida, 33161
Transgenomics
Omaha, Nebraska, 68164
Four Rivers Clinical Research
Paducah, Kentucky, 42003
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
Women's Health Research of Arizona
Phoenix, Arizona, 85015
Saginaw Valley Medical Research
Saginaw, Michigan, 48604
Center for Disease Detection (CDD)
San Antonio, Texas, 78233
Women's Health Care Research Corp
San Diego, California, 92111
West Coast Medical Research
San Diego, California, 92123
Fellows Research Associates - Savannah
Savannah, Georgia, 31406
Miami Research Associates
South Miami, Florida, 33143
Q Squared Solutions
Teterboro, New Jersey, 07608
Montefiore Medical Center
The Bronx, New York, 10461
Quality of Life Medical & Research Center
Tucson, Arizona, 85712
Visions Clinical Research
Tucson, Arizona, 85712
Tidewater Clinical
Virginia Beach, Virginia, 23456
Comprehensive Clinical Trials, LLC
West Palm Beach, Florida, 33409
Reading Health Physicians Network
West Reading, Pennsylvania, 19611
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103
About this study
The purpose of the study is to compare the results of the Becton Dickinson (BD) Onclarity™ Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology (LBC) media diluted in BD HPV LBC diluent to adjudicated histology results from biopsy and a molecular composite comparator.
- Conditions
- Uterine Cervical Neoplasms
- Being tested
- BD Onclarity™ HPV assay on BD Viper™ LT, Colposcopy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BD Onclarity™ HPV assay on BD Viper™ LTDevice
The BD HPV specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test.
ColposcopyProcedure or surgery
Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or random sampling of subject with normal cytology and HPV negative test results.
| Study group | Role | What they receive |
|---|---|---|
| BD Onclarity™ HPV assay on BD Viper™ LT | Experimental | The LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. Colposcopy will be performed on subjects who have abnormal cytology or HPV positive test results or from a random sampling of subjects with normal cytology and HPV negative test results. Receives: Device: BD Onclarity™ HPV assay on BD Viper™ LT; Procedure: Colposcopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater
Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater (multiplied by 100).
Measured: Up to 14 weeks
Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater
Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of CIN3 or greater (multiplied by 100).
Measured: Up to 14 weeks
Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater
Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of less than CIN2 (multiplied by 100).
Measured: Up to 14 weeks
Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater
Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of less than CIN3 (multiplied by 100).
Measured: Up to 14 weeks
Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).
Positive Predictive Value is calculated: Number of subjects with a positive result for the BD Onclarity™ HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.
Measured: Up to 14 weeks
Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).
Negative Predictive Value is calculated: Number of subjects with a negative result for the BD Onclarity™ HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.
Measured: Up to 14 weeks
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN2 or greater disease are to have that particular BD HPV Onclarity™ test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.
Measured: Up to 14 weeks
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN3 or greater disease are to have that particular BD Onclarity™ HPV test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.
Measured: Up to 14 weeks
Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
The Absolute Risk (AR) of CIN2 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.
Measured: Up to 14 weeks
Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
The Absolute Risk (AR) of CIN3 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.
Measured: Up to 14 weeks
Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN2 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.
Measured: Up to 14 weeks
Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN3 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.
Measured: Up to 14 weeks
Positive Percent Agreement of the BD Onclarity™ HPV Assay as Compared to a Composite HPV Comparator Incorporating Results for the Digene Hybrid Capture 2 (HC2) HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)
Positive percent agreement is calculated: Number of subjects with a positive BD Onclarity™ HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive (multiplied by 100).
Measured: Up to 14 weeks
Negative Percent Agreement of the BD Onclarity™ HPV Assay Compared to a Composite HPV Comparator Incorporating Results for the Digene HC2 HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)
Negative percent agreement is calculated: Number of subjects with a negative BD Onclarity™ HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative (multiplied by 100).
Measured: Up to 14 weeks
Non-reportable Rate of the BD Onclarity™ HPV Test
Non-reportable rate is calculated as the number of non-reportable BD Onclarity™ HPV test results divided by the total number of BD Onclarity™ HPV test results (multiplied by 100). Not included in this calculation are specimens that did not yield a result due to specimen labeling, processing and volume issues.
Measured: Up to 14 weeks
Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category.
Prevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category.
Measured: Up to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine Cervical NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33,858 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Cooper, MD, Study director, Becton, Dickinson and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944722
- Sponsor's protocol ID
- BDS-USHPV
- Status last verified
- May 2018
- First submitted
- 5 Sep 2013
- Last updated
- 12 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Stoler MH, Wright TC, Parvu V, Yanson K, Eckert K, Kodsi S, Cooper C. HPV Testing With 16, 18, and 45 Genotyping Stratifies Cancer Risk for Women With Normal Cytology. Am J Clin Pathol. 2019 Mar 1;151(4):433-442. doi: 10.1093/ajcp/aqy169.
PubMed 30649177Wright TC Jr, Stoler MH, Parvu V, Yanson K, Eckert K, Kodsi S, Cooper CK. Detection of Cervical Neoplasia by Human Papillomavirus Testing in an Atypical Squamous Cells-Undetermined Significance Population: Results of the Becton Dickinson Onclarity Trial. Am J Clin Pathol. 2019 Jan 1;151(1):53-62. doi: 10.1093/ajcp/aqy084.
PubMed 30189049Stoler MH, Wright TC Jr, Parvu V, Vaughan L, Yanson K, Eckert K, Karchmer T, Kodsi S, Cooper CK. The Onclarity Human Papillomavirus Trial: Design, methods, and baseline results. Gynecol Oncol. 2018 Jun;149(3):498-505. doi: 10.1016/j.ygyno.2018.04.007. Epub 2018 Apr 19.
PubMed 29681462
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the BD Onclarity™ HPV Assay on the BD Viper™ LT System With Cervical Specimens
- ClinicalTrials.gov ID
- NCT01944722
- Acronym / sponsor ID
- BDS-USHPV
- Conditions
- Uterine Cervical Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33,858 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Posted 18 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the results of the Becton Dickinson (BD) Onclarity™ Human Papilloma Virus (HPV) Assay on the BD Viper™ LT instrument from liquid-based cytology (LBC) media diluted in BD HPV LBC diluent to adjudicated histology results from biopsy and a molecular composite comparator.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BD Onclarity™ HPV assay on BD Viper™ LT | Experimental | Device: BD Onclarity™ HPV assay on BD Viper™ LT, Procedure: ColposcopyThe LBC specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. Colposcopy will be performed on subjects who have abnormal cytology or HPV positive test results or from a random sampling of subjects with normal cytology and HPV negative test results. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Females who are >21 years of age
- Females who provide informed consent
Key exclusion criteria (6 listed)
- Known pregnant
- Cervical cytology specimen collected within the last 4 months
- Prior complete or partial hysterectomy involving removal of cervix
- Application of chemical compounds to the cervical area 24 hour prior to study entry- acetic acid, iodine, spermicide, douche, or anti-fungal medications
- Conization, Loop Electrosurgical Excision Procedure (LEEP), cervical laser surgery or cryosurgery on the cervix has been performed in the last twelve months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BD Onclarity™ HPV assay on BD Viper™ LTThe BD HPV specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test. | Device | BD Onclarity™ HPV assay on BD Viper™ LT |
| ColposcopyColposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or random sampling of subject with normal cytology and HPV negative test results. | Procedure or surgery | BD Onclarity™ HPV assay on BD Viper™ LT |
Primary outcome
Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater
Time frame: Up to 14 weeks
Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of CIN2 or greater (multiplied by 100).
Sensitivity of the BD Onclarity™ HPV Assay for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater
Time frame: Up to 14 weeks
Sensitivity is calculated: Number of subjects with a positive BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of CIN3 or greater (multiplied by 100).
Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater
Time frame: Up to 14 weeks
Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN2 or greater divided by the total number of subjects with adjudicated histology results of less than CIN2 (multiplied by 100).
Specificity of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)3 or Greater
Time frame: Up to 14 weeks
Specificity is calculated: Number of subjects with a negative BD Onclarity™ HPV test with adjudicated histology results of CIN3 or greater divided by the total number of subjects with adjudicated histology results of less than CIN3 (multiplied by 100).
Positive Predictive Value (PPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).
Time frame: Up to 14 weeks
Positive Predictive Value is calculated: Number of subjects with a positive result for the BD Onclarity™ HPV test and adjudicated histology results of CIN2 or greater divided by the total number of subjects with positive result for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.
Negative Predictive Value (NPV) of the BD Onclarity™ HPV Assay for Detecting Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN).
Time frame: Up to 14 weeks
Negative Predictive Value is calculated: Number of subjects with a negative result for the BD Onclarity™ HPV test and histology results less than CIN2 divided by the total number of subjects with negative results for the BD Onclarity™ HPV test (multiplied by 100). Similar for CIN3 or greater.
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
Time frame: Up to 14 weeks
The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN2 or greater disease are to have that particular BD HPV Onclarity™ test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.
Likelihood Ratio for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
Time frame: Up to 14 weeks
The likelihood ratio for each BD Onclarity™ HPV test outcome summarizes how many times more (or less) likely subjects with CIN3 or greater disease are to have that particular BD Onclarity™ HPV test outcome than subjects without the disease. Significant likelihood ratios (defined in cases where 1 is not contained within the 95% confidence interval) indicate that a test result is informative.
Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
Time frame: Up to 14 weeks
The Absolute Risk (AR) of CIN2 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.
Absolute Risk for the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
Time frame: Up to 14 weeks
The Absolute Risk (AR) of CIN3 or greater disease for each BD Onclarity™ HPV test outcome is the probability of the disease for that particular BD Onclarity™ HPV test outcome. A higher absolute risk indicates a higher probability overall for an event to occur.
Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN2 or Greater).
Time frame: Up to 14 weeks
Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN2 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.
Relative Risk of the Detection of Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN3 or Greater).
Time frame: Up to 14 weeks
Relative Risk is the ratio between two different absolute risks. The relative risk of having CIN3 or greater disease will be evaluated to compare two different BD Onclarity™ HPV Assay test outcomes.
Positive Percent Agreement of the BD Onclarity™ HPV Assay as Compared to a Composite HPV Comparator Incorporating Results for the Digene Hybrid Capture 2 (HC2) HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)
Time frame: Up to 14 weeks
Positive percent agreement is calculated: Number of subjects with a positive BD Onclarity™ HPV test with composite comparator positive divided by the total number of subjects with composite comparator positive (multiplied by 100).
Negative Percent Agreement of the BD Onclarity™ HPV Assay Compared to a Composite HPV Comparator Incorporating Results for the Digene HC2 HPV Test and PCR/Sequencing on Both Strands of the PCR Amplicon (Bidirectional Sequencing)
Time frame: Up to 14 weeks
Negative percent agreement is calculated: Number of subjects with a negative BD Onclarity™ HPV test with composite comparator negative divided by the total number of subjects with composite comparator negative (multiplied by 100).
Non-reportable Rate of the BD Onclarity™ HPV Test
Time frame: Up to 14 weeks
Non-reportable rate is calculated as the number of non-reportable BD Onclarity™ HPV test results divided by the total number of BD Onclarity™ HPV test results (multiplied by 100). Not included in this calculation are specimens that did not yield a result due to specimen labeling, processing and volume issues.
Number of Participants With Cervical Intraepithelial Neoplasia (CIN)2 or Greater and CIN3 or Greater Within Each Cytology Category.
Time frame: Up to 14 weeks
Prevalence is calculated as the rate of CIN2 or greater and CIN3 or greater within each cytology category.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30649177Stoler MH, Wright TC, Parvu V, Yanson K, Eckert K, Kodsi S, Cooper C. HPV Testing With 16, 18, and 45 Genotyping Stratifies Cancer Risk for Women With Normal Cytology. Am J Clin Pathol. 2019 Mar 1;151(4):433-442. doi: 10.1093/ajcp/aqy169.
- Derived from this study: PubMed 30189049Wright TC Jr, Stoler MH, Parvu V, Yanson K, Eckert K, Kodsi S, Cooper CK. Detection of Cervical Neoplasia by Human Papillomavirus Testing in an Atypical Squamous Cells-Undetermined Significance Population: Results of the Becton Dickinson Onclarity Trial. Am J Clin Pathol. 2019 Jan 1;151(1):53-62. doi: 10.1093/ajcp/aqy084.
- Derived from this study: PubMed 29681462Stoler MH, Wright TC Jr, Parvu V, Vaughan L, Yanson K, Eckert K, Karchmer T, Kodsi S, Cooper CK. The Onclarity Human Papillomavirus Trial: Design, methods, and baseline results. Gynecol Oncol. 2018 Jun;149(3):498-505. doi: 10.1016/j.ygyno.2018.04.007. Epub 2018 Apr 19.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Cooper, MD study director
Becton, Dickinson and Company
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BD Onclarity™ HPV assay on BD Viper™ LT and Colposcopy in people with Uterine Cervical Neoplasms, run by Becton, Dickinson and Company at 41 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of the BD Onclarity™ HPV Assay for the Detection Cervical Disease as Defined by Cervical Intraepithelial Neoplasia (CIN)2 or Greater (time frame: Up to 14 weeks). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944722, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2018.